BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES

    MDR report key: 10457689 · Received August 26, 2020

    Report

    Report Number
    1917413-2020-00760
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    August 5, 2020
    Report Date
    September 18, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903630832
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 35 CUSTOMER SAMPLES FROM LOT 0072405 AND 41 CUSTOMER SAMPLES FROM LOT 0072406 WERE RETURNED FROM THE CUSTOMER FACILITY FOR EVALUATION. 10 CUSTOMER SAMPLES FROM EACH LOT WERE EVALUATED BY FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOTS WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. ADDITIONALLY, THE CUSTOMER SAMPLE TUBES WERE INSPECTED WITH 0 VISIBLE DEFECTS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TUBES UNDER FILLED DURING USE ON THREE OCCASIONS WITH 10 BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 2 COMPLAINTS) CUSTOMER STATES THAT TUBE UNDER FILLED ON THREE SEPARATE OCCASIONS. NOT KNOW AT THIS POINT IF A STRAIGHT VENIPUCTURE NEEDLE OR A WINGED COLLECTION SET WAS USED. WHAT WAS THE DATE OF EVENT? (B)(6) AND (B)(6). WERE THERE ANY PHOTOS TAKEN AT THE TIME OF THE INCIDENT? NO PHOTOS, EXAMPLES WERE GIVEN TO DEPARTMENT SUPERVISOR. AT THE TIME, MATERIAL¿S MANAGEMENT DID NOT REQUEST PHOTOS OR SAMPLES. HOW MANY UNITS (TUBES) AFFECTED? 10 TUBES TOTAL. WHAT IS THE LABELED DRAW VOLUME (2ML, 3MLETC) 2.7. WHAT WAS THE LEVEL OF TUBE FILL? A MIXTURE OF BOTH. NO FILL (FILL VOLUME IS NEAR ZERO); PARTIAL FILL; UNSURE. HOW WAS THE TUBE REJECTED (I.E.: AT THE COLLECTION, BY THE LAB, BY AUTOMATED FILL LEVEL SENSING, ETC.)? AT TIME OF COLLECTION. WHAT WAS THE TUBE¿S EXPIRATION DATE? 12/31/2021. HOW WAS THE TUBE DRAWN? WITH A 20G STRAIGHT NEEDLE. WAS A DISCARD TUBE USED? A DISCARD TUBE IS NOT NEEDED WITH A STRAIGHT NEEDLE. WAS A SUCCESSFUL DRAW ACHIEVED WITH THE SAME LOT? YES- TWO DIFFERENT LOTS. IS THIS HAPPENING WITH ONE PARTICULAR: DEPARTMENT, UNIT, AND SHIFT, TIME OF DAY OR PERSON- MULTIPLE PHLEBOTOMISTS AT AURORA WEST ALLIS MEDICAL CENTER.

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0072405, MEDICAL DEVICE EXPIRATION DATE: 2020-12-31, DEVICE MANUFACTURE DATE: 2020-03-12, MEDICAL DEVICE LOT #: 0072406, MEDICAL DEVICE EXPIRATION DATE: 2020-12-31, DEVICE MANUFACTURE DATE: 2020-03-12." A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TUBES UNDER FILLED DURING USE ON THREE OCCASIONS WITH 10 BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 2 COMPLAINTS) CUSTOMER STATES THAT TUBE UNDER FILLED ON THREE SEPARATE OCCASIONS. NOT KNOW AT THIS POINT IF A STRAIGHT VENIPUCTURE NEEDLE OR A WINGED COLLECTION SET WAS USED. WHAT WAS THE DATE OF EVENT? 8/5 AND 8/7. WERE THERE ANY PHOTOS TAKEN AT THE TIME OF THE INCIDENT? NO PHOTOS, EXAMPLES WERE GIVEN TO DEPARTMENT SUPERVISOR. AT THE TIME, MATERIAL¿S MANAGEMENT DID NOT REQUEST PHOTOS OR SAMPLES. HOW MANY UNITS (TUBES) AFFECTED? 10 TUBES TOTAL. WHAT IS THE LABELED DRAW VOLUME (2 ML, 3 ML ETC) 2.7. WHAT WAS THE LEVEL OF TUBE FILL? A MIXTURE OF BOTH. NO FILL (FILL VOLUME IS NEAR ZERO). PARTIAL FILL. UNSURE. HOW WAS THE TUBE REJECTED (I.E.: AT THE COLLECTION, BY THE LAB, BY AUTOMATED FILL LEVEL SENSING, ETC.)? AT TIME OF COLLECTION. WHAT WAS THE TUBE¿S EXPIRATION DATE? 12/31/2021. HOW WAS THE TUBE DRAWN? WITH A 20 G STRAIGHT NEEDLE. WAS A DISCARD TUBE USED? A DISCARD TUBE IS NOT NEEDED WITH A STRAIGHT NEEDLE. WAS A SUCCESSFUL DRAW ACHIEVED WITH THE SAME LOT? YES, TWO DIFFERENT LOTS. IS THIS HAPPENING WITH ONE PARTICULAR: DEPARTMENT, UNIT, AND SHIFT, TIME OF DAY OR PERSON. MULTIPLE PHLEBOTOMISTS AT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922273 BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 363083 SEE H.10 50382903630832

    Patients

    Seq Age Sex Outcome Treatment
    1 Other